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OncoMatch/Clinical Trials/NCT06943820

AK129 Combination Therapy for Advanced Solid Tumors

Is NCT06943820 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for non-small cell lung cancer stage iiib/iv.

Phase 1/2RecruitingAkesoNCT06943820Data as of May 2026

Treatment: AK129(dose 1) · Pemetrexed · Paclitaxel · Carboplatin · AK129(dose 2) · Docetaxel · Cis-platinum · 5-FU (5-fluorouracil) · Cetuximab · Paclitaxel · Docetaxel · Chemotherapy · AK129(RP2D) · PenpulimabThis is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Head and Neck Squamous Cell Carcinoma

Colorectal Cancer

Tumor Agnostic

Biomarker criteria

Excluded: EGFR sensitizing mutation

EGFR-sensitive mutations

Excluded: EGFR exon 20 insertion mutation

EGFR exon 20 insertion mutation

Excluded: ALK fusion

ALK fusion positivite

Excluded: ROS1 rearrangement

known ROS1 rearrangement

Excluded: MET exon 14 skipping mutation

MET exon 14 skipping mutation

Excluded: BRAF V600E mutation

BRAF V600E mutation

Excluded: NTRK1 fusion

NTRK gene fusion positivite

Excluded: NTRK2 fusion

NTRK gene fusion positivite

Excluded: NTRK3 fusion

NTRK gene fusion positivite

Excluded: RET fusion

RET gene fusion positivite

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy — locally advanced or metastatic NSCLC

must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy

Must have received: anti-PD-1 therapy — locally advanced or metastatic NSCLC

must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy

Must have received: platinum-based chemotherapy — recurrent or metastatic HNSCC

must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy

Must have received: anti-PD-1 therapy — recurrent or metastatic HNSCC

must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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